Adjusting catheter holding device

ABSTRACT

The present invention discloses catheter tube retaining devices having a disk rotatably coupled to the base, and a strap (or equivalent) for attaching such a device to the human body. The disk is capable of rotation relative to the base through at least a 90 degree arc. Further, the disk has formed upon a top surface at least one U-shaped retaining channel or groove of sufficient diameter as to retain a catheter tube in interference fit, without restricting the passage of fluid through such tube. Preferably, at least one pair of opposing tabs (or equivalent) protrude over the retaining channel to assist in the retention of the catheter tube. The disk can accommodate four channels, for different sizes of catheter tubes.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of provisional application 60/006,365 filed Nov.8, 1995 and U.S. patent application Ser. No. 08/745,658, filed Nov. 8,1996, now U.S. Pat. No. 5,690,617.

BACKGROUND OF INVENTION

This invention relates to a device for attaching a portion of the tubeor conduit portion of a catheter to the human body by use of a rotatabledisk, which has at least one catheter tube retaining channel, attachedto a base member.

Catheters are common devices employed in a variety of medicalprocedures. In general, catheters are defined as tubular medical devicesfor insertion into a canal, blood vessel, passageway or body cavityusually to permit the injection or withdrawal of fluids, to promotedrainage, and/or to keep the passageway open. Some catheters includeneedle portions, others do not.

A portion of a conventional catheter 10 is seen in FIG. 1. One end ofcatheter 10 (not shown) which has one or more holes therein, is insertedinto the human body while the other end of the catheter includes atleast one tube opening 11 for drainage. Depending upon the medicalprocedure desired, catheter 10 may have one or more additional tubeopenings, such as illustrated at 13. In this configuration, tube opening13 is used to inject a fluid (usually sterile water) into a conventionalcatheter balloon portion (not shown) for inflation of the balloon afterthe balloon has been inserted into a body cavity, such as a bladder.Tube opening 11 provides the pathway for withdrawal of body fluids, suchas urine. Other tube openings (not shown) on catheter 10 can also beemployed, such as to inject antibiotics for flushing out the body cavityor sterile fluid. Catheters of various diameter or sizes (e.g. 8, 10,12, 14, 16, 18, 20, 22, 24, 26 and 28) are commonly used with adults.

Catheters are usually manufactured from latex, polyurethane or rubber,but can be manufactured from other materials. For example, siliconcatheters are useful for extended medical treatments, while rigidcatheters are made for insertion into small children and babies. Becauseof their widespread use in varying medical procedures, several types ofcatheters exist which are manufactured for specialized medicalprocedures. For example, cardiac catheters include a flexible tube witha balloon-like tip that is threaded into a patient's coronary arteriesduring an angioplasty procedure and then inflated to flatten materialthat is clogging the arteries and obstructing blood flow. Similarly,catheters can also be used for alveolar lavage in respiratory diseasetherapy, while other types of catheters include, but are not limited to,rectal catheters, nasal catheters, epidural catheters and intravascularultrasound (IVUS) catheters. Finally, catheters for urological orincontinence purpose (known as "foley" catheters) are also commonlyknown. There are several manufacturers of catheters, including TrekMedical of Tampa, Florida, Baxter Healthcare Corporation of McGaw Park,Ill., C. R. Bard of Covington, Ga. and Abbott Labs of North Chicago,Ill.

The term catheter is also applied to intravenous tubes ("IV tubes")which are typically used to permit the injection or withdrawal of fluidsfrom the body. Similarly, several medical techniques incorporateelectrical signal wire similar to a catheter's use, as such wires can beuseful for stimulating (e.g., injecting) or monitoring (e.g.,withdrawing) information from the human body.

After a catheter is inserted in the human body, the portion of thecatheter which is external to the body is usually attached to the bodyat one or more locations. This is a recommended procedure for severalreasons. First, because the catheter is usually directly coupled to ahuman cavity (e.g., such as a heart, vein or a bladder), any movement ofthe catheter near its entrance to the body may also result in movementof the catheter within the body. If the movement is continuous orrepetitive, this will likely result in irritation to the body cavity andpotentially result in infection. Second, several forms of cathetersutilize a balloon to retain one end of the catheter in the body cavity.As the catheter moves external to the body, the balloon similarly moves,resulting in friction between the tissue of the body cavity and theballoon. If this friction continues, the cavity tissue may begin tobleed. This is a common occurrence in urinary catheters, as bloodfrequently is found in urinary bags which are attached to a urinarycatheter. It is believed that some, if not all, of this blood is theresult of the friction between the catheter and the urinarytract/interior bladder surface.

Several methods exist for attaching the catheter to the body. Forexample, if the catheter is employed for incontinence or urologicalpurposes, the catheter tube can be placed on men either on the inner orouter thigh through the use of adhesive tape, while in women, cathetersare generally placed on the inner thigh. When attached to the human legby adhesive tape, the catheter is initially snugly affixed between theleg and the adhesive tape. However, as a person continues to move in anatural manner, the tape adhesive loses its adhesion to the catheter,but generally remains adhesive to the human skin. In this situation, thecatheter is no longer snugly fit between the tape and the skin, andbegins to rub against the skin or body hair thereby irritating the skin.Naturally, this condition can be extremely painful to the patient, andcan also result in infection if not properly treated.

In other applications, the catheter portion extending from the body canalso be attached to the body by means of a conventional rubber or Velcrostrap. These types of straps are usually included with smallerincontinence bags which are used by patients with a urological catheterwhen traveling. While flexible, these types of straps are not effectiveat retaining the catheter in a stable position relative to bodymovement. For example, these straps, if not wrapped around the bodyproperly, tend to slip off the body as it moves. Conversely, if thestrap is too tight, it tends to irritate the skin whether or not thebody moves, and could lead to infection of the skin. Further, if thestrap is worn, old or contains a manufacturing defect, it could break,thereby allowing the catheter to freely swing without any retention tothe body.

Finally, in some applications, catheters are purposely not attached tothe body, but are allowed to freely swing. This is rarely a recommendedprocedure, as catheters such as IV tubes, can easily be displaced fromthe human body as it moves. Additionally, the freely swinging cathetercan be unintentionally moved (such as during sleep) so as to result inextreme irritation and severe pain to the patient.

There are also well-known, severe problems associated with catheters'ripping out of patients when catheter tubes accidentally are caught onobstructions during patient transport causing injury and bleeding.Similarly, catheters can be ripped out, yanked out or otherwise causeinjury when patients are walking and they step on the catheter tube.

Several other known problems exist in using catheters not related totheir attachment to the body. For example, because catheters aretypically constructed from pliable material, they tend to kink when bentbeyond 45 degrees, thereby resulting in blockage of the catheter. Whenkinking occurs in urology catheters, fluid pressure within the bladderincreases to the point that the fluid eventually seeps out of the humanbody resulting in an uncontrolled leakage. Further, this type ofsituation is likely to occur when a patient is asleep because as thepatient normally moves throughout the night, the catheter similarlymoves. If the catheter moves so as to bend beyond 45 degrees, it willlikely block the fluid passage.

If catheter movement during normal body movement can be reduced and/oreliminated, it is believed that infection rates can be drasticallyreduced. Clearly, a need exists for retaining the external portion ofthe catheter in a stable position relative to the body during normalmovement, to prevent irritation and pain from both the internal andexternal portions of the human body.

Catheter needle locating devices are disclosed in U.S. Pat. Nos.4,585,443 and 4,666,434, both issued to J. M. Kaufman. Kaufman '443discloses a device for securing catheter needles to grafts and the likeimplanted in patients, primarily for use in connection with dialysistreatment. The device includes an anchoring bracelet for attachment tothe patient at a predetermined location at which the graft is located,and a rotatable saddle mounted in the anchoring bracelet, which saddleincludes an aperture adapted to receive the needle portion of thecatheter. The device also includes a contact surface having a shapeadapted to mate with the graft, and a saddle channel extending betweenthe aperture and the contact surface, so that the needle projects apredetermined distance from the contact surface when it has beeninserted into the aperture, thereby permitting the needle to beaccurately located in the graft and firmly anchored on the patient. Inparticular, when the device has been applied to the patient, as shown inFIG. 1 of Kaufman '443, the axis of rotation of the saddle will beperpendicular to the patient's skin. Thus, after application of thedevice to the patient, but prior to insertion of the needle, finealignment between the needle and the graft can be affected by rotationof the saddle about its axis of rotation by a small degree. Similarly,Kaufman '434 discloses a device for securing catheter needles to graftsimplanted in patients.

Accordingly, it is an object of the present invention to provide acatheter tube retaining device for use with a catheter tube, an IV tube,and electrical signal wires or like tubular structures, capable ofretaining a portion of the tube or conduit portion of a catheter whilesimultaneously allowing rotational movement relative to the body as thebody moves.

It is also an object of the present invention to provide a catheter tuberetaining device having a base, a rotatable disk having at least onechannel (or equivalent) for retaining a portion of the tube or conduitportion of a catheter and a pin attaching the base to the disk, toretain such portion of the catheter tube in a stable but rotatableposition relative to the human body which results in minimal or nomovement of the internal portion of the catheter.

It is a further object of the present invention to provide a catheterretaining device having a base and an attached rotatable disk having atleast one channel (or equivalent) for retaining a portion of the tube orconduit portion of a catheter to prevent an external portion of suchcatheter tube from bending beyond a 45 degree angle, to thereby preventtube kinking or blockage.

This invention improves both catheter use and safety, and furtheralleviates or reduces any patient irritation or pain associated withusing a catheter.

SUMMARY OF INVENTION

A catheter tube holding device, including a base and a disk whichincludes structure for holding a length of catheter tubing. The devicealso includes structure to rotatably couple the disk to the base,whereby the disk, when it is holding a length of tubing, can rotatethrough (at least) a 90° arc, and a strap or other similar device forattaching the base to a human. Preferably, the structure for holdingincludes at least one longitudinal u-shaped groove in the disk, whichhas a diameter slightly smaller than the diameter of the length oftubing to be inserted therein. Also, preferably, the disk includes atleast one pair of tabs or equivalent, which tabs are on opposite sidesof and partially project over the longitudinal groove, to assist inholding the length of tubing in the longitudinal groove. The device mayinclude at least one additional longitudinal u-shaped groove formed inthe disk, in which case the diameter of the additional longitudinalgroove is smaller than the diameter of the first longitudinal groove,whereby catheter tubes of different diameters can be accommodated. Theadditional longitudinal groove may be parallel to or at an angle to andintersecting the first longitudinal groove. The device may also includethird and fourth longitudinal u-shaped grooves formed in the disk, twoof the longitudinal grooves being parallel to each other and,simultaneously, perpendicular to the other two longitudinal grooves. Inthis last arrangement, the grooves accommodates catheter tube sizes8-12, 14-18, 20-24, and 26-28. The diameter of the longitudinal groovesslightly compresses the length of tubing, without restricting the flowof fluid through such length of tubing.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a top view of the first embodiment of the present invention;

FIG. 2 is a side cross-sectional view of the first embodiment as shownalong lines A--A in FIG. 1, without the detachable strap and cathetertubes;

FIG. 3 is a top view of the base of the first embodiment;

FIG. 4 is the top view of the disk of the first embodiment;

FIG. 5 is the exploded side view of the second embodiment of theinvention; and

FIG. 6 is the top view of the disk portion of the embodiment of FIG. 5.

DETAILED DESCRIPTION OF INVENTION

As seen in FIG. 1, catheter retaining device 21 includes base 23, disk25, and conventional strap 27 which is flexible and expandable innature.

As shown in FIG. 3, base 23 includes a center portion 31, having strapattachment portions 33 and 35 disposed on opposite sides thereof. Whilecenter portion 33 is of generally circular shape in the preferredembodiment, those skilled in the art will realize that the shape andsize of base 23 is not critical as long as base 23 provides a solid,stable foundation for disk 25. Handle portions 33 and 35 extend outwardfrom center portion 31 a short distance. Strap slots 37 and 39 formedwithin handle portions 33 and 35 respectively, are designed to receiveand secure strap 27 to base 23.

Similar to base 23, disk 25 is preferably circular in shape, but notnecessarily limited to that particular geometry. At least one retainingchannel 41 is longitudinally formed in disk 25. As illustrated in FIGS.2 and 4, retaining channel 41 is generally formed as a U-shaped groove,and is formed at a sufficient depth and diameter as to retain a cathetertube (such as tube portion 10a) in an interference friction fit. Thewidth of channel 41 should be sufficient to accommodate a range of sizes(e.g. 14-18, 20-24, etc.). As such, the diameter of retaining channel 41should be slightly smaller than the diameter of the largest sizecatheter tube 10a to be retained. Additionally, those skilled in the artwill appreciate that one or more additional U-shaped retaining channels,such as channel 43, can be formed in disk 25 for retaining a multitudeof catheter tubes of another range of sizes (e.g., 8-12), such asindicated by tube portion 15a of catheter 15.

For channel 41, two pair of opposing tabs 45-47 are integrally formedupon and are flush with disk top surface 49 to assist in retaining thelength of catheter tube 10a within retaining channel 41. Naturally,additional opposing tabs can be formed along the length of retainingchannel 41. Opposing tabs 45-47 protrude over retaining channel 41 ashort distance, but should not interfere with the quick insertion of andthe quick release of catheter tubes as may be required during a medicalemergency.

Further, while tabs 45-47 can be formed in facing relation, they canalso be offset throughout the length of retaining channel 41 as designconsiderations may require. Similarly, channel 43 is provided with twopair of opposing tabes 51-53, as illustrated in FIGS. 1, 2 and 4.

In another embodiment, not shown, U-shaped channel 41 can be replacedwith retaining prongs having a U-shaped cross section upon top surface49. In this fashion, cost savings and efficiency of space may beachieved as those skilled in the art will realize that a disk ofnarrower dimensions can be employed, while still achieving the noveltyof the present invention.

Disk 25 is rotatably coupled to base 23 through any conventionalcoupling device which permits relative rotation of disk 25 to base 23,so long as such device does not interfere with or block the open ends(41a, 41b) of channel 41, or the open ends (43a, 43b) of channel 43, asdisk 25 rotates relative to base 23. As seen in FIG. 2, coupling pin 55allows disk 25 to rotate on a center axis relative to base 23. Pin 55,which is received in openings 65 and 67, is of sufficient length as toallow one end 59 to be flush with base bottom surface 61, and to allowanother end 63 to be flush with top surface 49 of disk 25. Naturally,those of skill in the art will realize that coupling pin 55 can beintegrally formed with base 23 for manufacturing convenience andpotential cost savings. While disk 25 is capable of 360 degree rotationrelative to base 23, due to the orientation of device 21 as it isattached to a patient, disk 25 is limited in normal use to a 90 degreerotational arc.

Base 23, disk 25 and pin 55 can be constructed of any lightweight, rigidmaterial such as plastic suitable for hospital and patient use. In oneembodiment, the bottom surface 61 of base 23 can be curved to follow thecontour of the human body. Further, a soft material such as terry cloth,or an adhesive material can be applied to bottom surface 61 of base 23as medical needs require. In this regard, a soft surface will preventchafing and irritation of the skin, while an adhesive surface may beuseful in situations where a strap is undesirable, such as when thepatient is bathing.

In operation, catheter tube 10a is secured catheter retaining device 21naturally forces disk 25 to rotate and swivel automatically relative tobase 23 as the human body moves. The rotation of disk 25 is due to thenatural inclination of a catheter tube to move as the human body moves.

With reference to FIGS. 5 and 6, catheter retaining device 71 includes abase 73 and a rotatable disk 75. Base 73 has the same general shape asbase 23, circular with handle portions 77 and 79 (which, in turn,include slots 81 and 83). Base 73, which is preferably molded of virginpolyurethane, includes an integral, central, upstanding post 85 with anenlarged head 87. The bottom 89 of base 73 also includes a longitudinalslot (not shown), interconnecting slots 81 and 83, to accommodate astrap (such as strap 27).

Disk 75, which is also preferably molded of virgin polyurethane,includes four channels 91, 93, 95 and 97. Channels 91 and 93 areparallel to each other and perpendicular to channels 95 and 97. Asexemplified in FIG. 5, all four channels are U-shaped in cross-section,with the upper portions curved inward, to form lips, as indicated by 99,101 and 103, 105, which extend the length of the associated channel.Disk 75 also includes a central aperture 107 which receives post 85,whereby disk 75 rotates relative to base 73 about axis 109. Aperture 107includes a groove (not shown) which receives head 87 to hold the twoparts in mating engagement.

As is evident from FIG. 6, the channels 91, 93, 95 and 97 are ofprogressively increasing width, to accommodate catheter tube sizes 8-12,14-18, 20-24 and 26-28. Thus, for instance, the width of channel 91 isdesigned to be small enough to hold catheter tube sizes 8-12 with atleast some friction, to prevent such tubes from moving longitudinally inchannel 91. The surface of grooves 91, 93, 95 and 97 could be slightlyroughed to further reduce the possibility of slipping.

Operation of retaining device 71 is the same as that of retaining device21.

Whereas the drawings and accompanying description have shown anddescribed the preferred embodiments of the present invention, it shouldbe apparent to those skilled in the art that various changes may be madein the form of the invention without affecting the scope thereof.

I claim:
 1. A catheter tube holding device, said device comprising:a. abase for engagement with the skin of a human; b. means for removablyattaching said base to the human; c. a disk, said disk including meansfor holding a length of catheter tubing; and d. means for rotatablycoupling said disk to said base for rotation about an axis substantiallyperpendicular to the skin, whereby said disk, when holding said lengthof catheter tubing, can rotate through an arc about said perpendicularaxis.
 2. The device according to claim 1, wherein said means for holdingincludes at least one first longitudinal u-shaped groove in said disk.3. The device according to claim 2, wherein said first longitudinalu-shaped groove has a diameter slightly smaller than the diameter ofcatheter said length of tubing to be inserted therein.
 4. The deviceaccording to claim 2, wherein said disk includes at least one pair oftabs, which tabs are on opposite sides of and partially project oversaid longitudinal groove, to assist in holding said length of tubing insaid longitudinal groove.
 5. The device according to claim 2, furtherincluding a second longitudinal u-shaped groove formed in said disk. 6.The device according to claim 5, wherein said second longitudinal groovehas a diameter which is smaller than the diameter of said firstlongitudinal groove, whereby catheter tubes of different diameters canbe accommodated.
 7. The device according to claim 5, wherein said secondlongitudinal groove is at an angle to and intersects said firstlongitudinal groove.